Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management

University of Baghdad

Status and phase: Unknown; Phase 2

Conditions: Covid-19; SARS Pneumonia

Treatments: Drug: Niclosamide Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04753619

PRO2021070003

Details and patient eligibility

About

Assessment of the Effectiveness of Niclosamide as Add on Therapy to the Standard of care Measures in COVID-19 Management in a randomized controlled clinical trial

Full description

Protocol of therapy Niclosamaide Add on group

• NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. [ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days]
• If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.

Control group The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient:

• Acetaminophen 500mg on need
• Vitamin C 1000mg twice/ day
• Zinc 75-125 mg/day
• Vitamin D3 5000IU/day
• Azithromycin 250mg/day for 5 days
• Oxygen therapy/ C-Pap if needed
• Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
• Mechanical ventilation, if needed

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with age above 18 years and of any gender.
2. Definite diagnosis of COVID-19 according to the WHO classification criteria ( 18).
3. Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases, and no more than one day after being critical cases.
4. Understands and agrees to comply with planned study procedures.

Exclusion criteria

1. Patients refuse to enrol in the study
2. Patients with hypersensitivity or severe adverse effects to niclosamide
3. Renal impairment
4. Hepatic impairment
5. Pregnancy or a desire to become pregnant
6. Breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Niclosamide group: NCS group

Experimental group

Description:

NCL + standard therapy

Treatment:

Drug: Niclosamide Oral Tablet

Control group

No Intervention group

Description:

Control group